Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is an increase over the number of companies cited in the previous year.
Of the nine citations issued, the most common citation was 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established'.
Most of the companies cited were involved in the Devices sector.
Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
Jatex, Inc. | Devices | 06/15/2023 | Process control procedures, Lack of or inadequate procedures |
Jatex, Inc. | Devices | 06/15/2023 | Lack of or inadequate complaint procedures |
Martin Farm - Konrad Martin | Veterinary | 06/21/2023 | ELDU - producer causes Illegal drug residue |
Martin Farm - Konrad Martin | Veterinary | 06/21/2023 | Drugs prohibited for extralabel use in food-producing animal(s) |
Martin Farm - Konrad Martin | Veterinary | 06/21/2023 | Record keeping |
NG Instruments, Inc. | Devices | 12/14/2023 | Lack of or inadequate process validation |
NG Instruments, Inc. | Devices | 12/14/2023 | Lack of or inadequate In-process acceptance procedures |
NG Instruments, Inc. | Devices | 12/14/2023 | Nonconforming product, Lack of or inadequate procedures |
OrthoPediatrics Corporation | Devices | 08/18/2023 | Lack of or inadequate complaint procedures |